Depidex Pour-On Solution 0.5% w/v

Introduction

Company name: Novartis Animal Health UK Ltd

Address: Frimley Business Park

Frimley

Camberley

Surrey

GU16 7SR

Telephone: 01276 694402

Fax: 01276 694403

Presentation

A clear solution containing ivermectin 0.5% w/v (5 mg/ml).

Uses

This product is indicated for the effective treatment and control of the following gastrointestinal roundworms, lungworms, warbles, chorioptic and sarcoptic mange mite and sucking and biting lice of beef cattle and non-lactating dairy cattle.

Gastrointestinal roundworms (adult and fourth stage larvae): Ostertagia ostertagi (including inhibited O ostertagi), Haemonchus placei, Trichostrongylus axei, Trichostrongylus colubriformis, Cooperia spp, Oesophagostomum radiatum, Strongyloides papillosus (adult), Trichuris spp (adult)

Lungworms (adults and fourth stage larvae): Dictyocaulus viviparus

Warbles (parasitic stages): Hypoderma bovis and Hypoderma lineatum

Lice: Linognathus vituli, Haematopinus eurysternus, Solenopotes capillatus, Damalinia bovis.

Mange mites: Chorioptes bovis, Sarcoptes scabiei var. bovis.

Dosage and administration

Depidex Pour-on given at the recommended dose of 500 micrograms ivermectin per kg bodyweight controls infections with: Trichonstrongylus axei and Cooperia spp acquired up to 14 days after treatment; Ostertagia ostertagi and Oesophagostomum radiatum acquired up to 21 days after treatment; Dictyocaulus viviparus acquired up to 28 days after treatment. It also controls horn flies (Haematobia irritans) for up to 35 days after treatment.

To ensure administration of a correct dose, body weight should be determined as accurately as possible; accuracy of the dosing device should be checked. If animals are to be treated collectively rather than individually, they should be grouped according to their bodyweight and dosed accordingly, in order to avoid under or over dosing.

To obtain optimal benefit from the persistent activity of Depidex Pour-on, it is recommended that calves which are set-stocked in their first season of grazing should be treated 3, 8 and 13 weeks after turn-out. Studies have demonstrated that first-season grazing calves turned out to pasture in late April or May and treated with Depidex Pour-on 3, 8 and 13 weeks after turn-out can be protected from parasitic gastro-enteritis and lungworm disease throughout the grazing season, provided they are set-stocked. All calves should be included in the programme and no untreated cattle should be added to the pasture.

Treated calves should always be monitored according to good husbandry practices.

Dosage

1 ml per 10 kg bodyweight (based on a dosage level of 500 micrograms/kg bodyweight).

Administration

The formulation should be applied along the mid-line of the back in a narrow strip between the withers and tailhead.

Contra-indications, warnings, etc

Care should be taken to avoid the following practices because they increase the risk of development of resistance and could ultimately result in ineffective therapy:

- Too frequent and repeated use of anthelmintics from the same class, over an extended period of time.

- Underdosing which may be due to underestimation of body weight, misadministration of the product or lack of calibration of the dosing device (if any).

Suspected clinical cases of resistance to anthelmintics should be further investigated using appropriate tests (e.g. Faecal Egg Count Reduction Test). Where the results of the test(s) strongly suggest resistance to a particular anthelmintic, an anthelmintic belonging to another pharmacological class and having a different mode of action should be used.

Resistance to ivermectin (an avermectin) has been reported in Cooperia oncophora in cattle within the EU, in Teladorsagia in cattle in developed countries such as New Zealand and Haemonchus in cattle outside the EU. Therefore, the use of this product should be based on local (regional, farm) epidemiological information about susceptibility of nematodes and recommendations on how to limit further selection for resistance.

HIGHLY FLAMMABLE, KEEP AWAY FROM HEAT, SPEAKS, OPEN FLAME OR OTHER SOURCES OF IGNITION.

Do not treat cattle when their hair or hide is wet. Do not treat cattle if rain is expected, as rain within two hours of treatment may reduce efficacy. Do not apply to areas of skin which have mange, scabs or other lesions or to areas contaminated with mud or manure.

The product can be safely administered to cattle during pregnancy or lactation.

No signs of toxicity are likely up to to 5 mg/kg (ten times the recommended dose rate). There is no known antidote.

The product has been formulated specifically for use in cattle. It should not be applied or administered to other species, as adverse reactions, including fatalities in dogs may occur.

Depidex Pour-on may be irritating to human skin and eyes and the user should be careful not to apply it to himself or other persons. Operators should wear nitrile rubber gloves and boots with a waterproof coat when applying the product. Protective clothing should be washed after use. If accidental skin contact occurs, wash the affected area immediately with soap and water. If accidental eye exposure occurs, flush the eyes immediately with water and seek medical advice. do not smoke or eat while handling the product. Wash hands after use. Use only in well ventilated areas or outdoors.

For animal treatment only.

Keep out of the reach and sight of children.

Withdrawal Periods

Meat - Animals must not be slaughtered for human consumption during treatment. Cattle may be slaughtered for human consumption only after 28 days from the last treatment.

Milk - Do not use in cows producing milk for human consumption. Do not use in non-lactating dairy cows including pregnant heifers within 60 days of calving.

Pharmaceutical precautions

Following withdrawal of the first dose, use the product within 1 year. Discard unused material.

Close container when not in use and store in an upright position. Containers should be stored in their original boxes when not in use. Keep upright when filling and during storage.

Do not store above 30°C. If stored at temperatures below 0°C, the product may appear cloudy. If the product is brought back to room temperature the normal appearance will be restored without affecting efficacy.

No smoking. Keep away from sources of ignition.

Protect from light.

Container Disposal

IVERMECTIN IS EXTREMELY DANGEROUS TO FISH AND AQUATIC LIFE. Any unused veterinary medicinal product or waste materials derived from such veterinary medicinal products should be disposed of in accordance with local requirements. Do not contaminate ponds, waterways and ditches with the product or used container.

Legal category

POM-VPS

Packaging Quantities

250ml twin-neck pack with a squeeze-measure-pour system or 1 litre and 2.5 litre collapsible backpacks.

Further information

Ivermectin belongs to the avermectin [3-AV] class of anthelmintic in the endectocides. Chemical group of anthelmintic endectocides [3-AV].

Marketing authorisation number

Vm 12501/4064.